FDA Dietary Supplement Regulation

Be sure your dietary supplements are compliant. We help you develop regulatory strategies, design clinical studies, as well as guide you to market your products, and stay compliant with FDA regulations.

Dietary Supplements in USA

Dietary supplements are products that contain dietary ingredients, including minerals, vitamins, herbs, amino acids, botanicals, and other categories of ingredients that can be used to supplement diets. The dosage forms of dietary supplements are tablets, powders, capsules, energy bars, liquids. The supplements are used to compensate for diets, health conditions, or eating habits that decrease the consumption of essential vitamins and nutrients. 

Based on the CRN Consumer Survey on Dietary Supplements conducted in 2019, 77% of Americans consume dietary supplements. The majority of both are males and females, aged 18+ years. Among the age groups, adults between the ages of 35 – 54 years share 18% consumption, the highest usage of dietary supplements. Consequently, the nutritional supplement industry is witnessing massive growth, primarily in vitamins and protein supplements.

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Proven Expertise. Companies who have Trusted Us to Become Regulatory Compliant with Health Canada

Shams W.Pawel Amazing Grass

“We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions.”

Michael MT Consulting

I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.

Donal Gauvreau Sapro

I've used QSS services for many years now and they always deliver a very professional service. Everyone on the team is great to work with and the always come up with great solutions for your needs at a great price!

Why the Need for Dietary Supplement Regulations

FDA governs Dietary Supplements. Failure to be compliant with the regulations can cause expensive future corrective actions and even suspension of your dietary supplement. It may lead you to be ineligible for entry into the US market. As a manufacturer, importer, or distributor of dietary supplements and dietary ingredients, you’re solely responsible for assessing the safety and labeling of your products. You must ensure products adhere to all the requirements of FDA and DSHEA regulations.

Labeling Requirements

You must follow the labeling requirements, such as nutrition labeling, ingredient labeling, and nutrient content, dietary supplement packaging regulations, etc.

Supplement Facts Panel

Having a ‘Supplement Facts Panel’ is mandatory for every dietary supplement to be marketed in USA. The panel must have all information required by FDA.

Notification to FDA

According to Federal Food, Drug, and Cosmetic Act, FDA must be notified within 30 days of your dietary supplement first marketed in USA.

Clinical Trials

FDA and FTC require health claims about the safety of your dietary supplements that must be supported with reliable scientific evidence.

Types of Dietary Supplement Labels We Have Reviewed

We have reviewed a wide range of Dietary Supplement Product Labels, including but not limited to below

Sports Nutrition
Greens
Probiotics
Multi Vitamins
Nootropics
Beauty Enhancers
Aromatherapy
Anti-Oxidants
Traditional Medicine
Gummies

End to End Solutions for Dietary Supplements in USA

Our Cannabis License team consists of professionals who have extensive Cannabis, Food, Pharma, Medical Device, and Drug regulatory, licensing experience and are adept in new cannabis regulations, Canada. With in-house Health Canada inspectors, former employees of cannabis licensed producers, we are able to deliver turnkey solutions to grow your business.

Dietary Supplement Label Review

Our US regulatory specialists will review your label, Supplement Facts Panel (SFP), Structure-function claims, and give suggestions to meet labeling requirements and ensure SFP is in the correct format

Supplement Facts Panel Creation

Our officers will assist you in creating Supplement Facts Panel with adequate attention to box, font, thickness, etc., and ensure it strictly adheres to the required format and remain print-ready.

Health Claims Substantiation Dossier

We will empower you to prepare dossiers for supporting the efficacy and safety of your dietary ingredients according to the standards of evidence as described in the Federal Act.

Structure-Function Claims pre-market Notification

Do not worry about structure-function claim notification as our specialists will assist you in preparing the structure-function claim notification and submitting it through mail or electronically.

Dietary Supplement Foreign Facility U.S. Agent Service

We cater to all criteria required to serve as a US agent. With expert knowledge and extensive experience, we are able to answer every question the FDA may have in case of an emergency.

Dietary Supplement Facility Registration and Renewal

Our US Regulatory experts will help you register or renew your food or dietary supplement facility with FDA. We make the entire registration and renewal process simple and cost-effective

New Dietary Ingredient Notification (NDIN)

We determine if your ingredient is a New Dietary Ingredient, prepare a full dossier for a New Dietary Ingredient Notification, request for FDA pre-submission meeting, and address any questions asked by the FDA.

Prior Notice FDA Clearance

If you are shipping dietary supplements into the United States a Prior Notice must be filed prior to arrival. An FDA confirmation with a bar code must accompany most dietary supplements at port of entry.

Do you know?

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